(90 days)
The Mediport 2000 suction device can be generally used in the ENT sector and is equally suitable for both in-patient and outpatient purposes. It can be used for faryngectomy and in the event of heavy secretion in one of the organisms or other operations in the mouth and throut area. The mobile may only be used for the applications listed above.
Mediport 2000 Mobile is a powered suction pump.
Here's an analysis of the provided text, focusing on the request for acceptance criteria and study details.
Limitations of the Provided Text:
The provided text is an FDA 510(k) clearance letter for a medical device called "Mediport 2000 Mobile." This type of document primarily confirms that a new device is "substantially equivalent" to an already legally marketed device (predicate device). It does not generally contain detailed information about specific acceptance criteria or the full study reports that were submitted for the clearance.
Therefore, the following answers are based only on the information that can be inferred or explicitly stated in the provided FDA letter. Many sections will be marked as "Not provided in the document" because the letter's purpose is not to disseminate this level of detail.
Acceptance Criteria and Study for Mediport 2000 Mobile
Summary:
The provided document is an FDA 510(k) clearance letter indicating that the Mediport 2000 Mobile suction device has been found substantially equivalent to a predicate device. This letter signifies regulatory approval for marketing based on a comparison to an existing device, rather than a presentation of direct performance against specific, pre-defined acceptance criteria. The letter itself does not explicitly list the acceptance criteria or a detailed study report.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The 510(k) clearance process relies on demonstrating "substantial equivalence" to a predicate device, which implies meeting similar performance characteristics. Specific performance metrics (e.g., suction pressure, flow rate, reservoir capacity, noise level, reliability) would have been part of the submission but are not detailed in this clearance letter. | Not explicitly stated in the document. The device is cleared for the indicated uses, implying its performance is sufficient for those uses and comparable to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not provided.
- Data Provenance: Not provided. The submission would have included testing data, but its origin (e.g., country, retrospective/prospective nature) is not specified in this clearance letter.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not provided. Given the nature of a powered suction pump, ground truth for performance claims typically comes from engineering and functional testing, not expert clinical interpretation of images or patient outcomes in the same way an AI diagnostic device would.
4. Adjudication Method for the Test Set
- Not provided. Not applicable in the context of device performance testing for a powered suction pump, which would involve objective measurements rather than subjective expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No. An MRMC study is relevant for diagnostic devices interpreting medical images or data by human readers. A powered suction pump is a therapeutic device, and this type of study would not be applicable.
- Effect Size (AI vs. without AI assistance): Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done?: Not applicable. The Mediport 2000 Mobile is a physical medical device (powered suction pump), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply. Performance testing would focus on the physical and functional aspects of the pump.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated, but for a powered suction pump, ground truth would typically be established through objective engineering measurements (e.g., suction pressure achieved, flow rate, vacuum maintenance, reservoir integrity, sterile barrier testing if applicable, electrical safety, biocompatibility of materials). It would not be based on expert consensus, pathology, or outcomes data in the same way a diagnostic device would.
8. Sample Size for the Training Set
- Not applicable. The Mediport 2000 Mobile is a hardware device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol with flowing lines, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2002
Mr. Martin Herberg Export-Manager Servox Medizintechnik GmbH Servatiusstrasse 69 d, 51109 Köln, Germany
Re: K013585
Trade/Device Name: Mediport 2000 Mobile Regulation Number: 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: October 12, 2001 Received: October 30, 2001
Dear Mr. Herberg:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector. 3 ro(x) premier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) w the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1970, as easily the provisions of the Federal Food, DNI, 3 devices that have boon require approval of a premarket approval application (PMA). and Costinctle rice (11ct) that to nevice, subject to the general controls provisions of the Act. The r ou may, morelore, mains of the Act include requirements for annual registration, listing of general ocures, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it rr your device is classince (soo are rols. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not nean r rouse of acribed a determination that your device complies with other requirements of the Act that I Dr Has Internations and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Martin Herberg
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
isiam C. Provost
Cot Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510 (k) NUMBER (IF KNOWN) : K013585 -----
MEDIPORT 2000 mobile____ DEVICE NAME:
The Mediport 2000 suction device can be INDICATIONS FOR USE: generally used in the ENT sector and is equally suitable for generally used in the ENT Seconal patients. It can be used for faryngectomy and outpatient purposes. both in-patient and outpactent portion event of heavy secretion The device is designed introse in one of the organisms or other operations in the mouth and throut area. operations in the mobile may only be used for the applications listed above.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use_ (Optional Format 1-2-96)
Muriam C. Parrott
510(k) Number K013585
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.